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目的采用腹腔致敏静脉激发、口鼻雾化致敏激发两种不同给药途径观察动物给予灯盏花素注射液后,是否产生竖毛、咳嗽、呼吸困难甚至死亡等全身过敏反应。方法将豚鼠分为阴性吸入组、阴性注射组、阳性吸入组、阳性注射组,灯盏花素注射液0.32和1 mg/kg吸入组、注射组。致敏阶段,灯盏花素注射液吸入组动物分别吸入不同浓度等体积的药液,隔日给药,共3次;同时注射组动物分别腹腔注射与上述浓度、体积相同的药液。激发阶段,吸入组动物于末次致敏后第14、21天吸入不同浓度的灯盏花素注射液,注射组动物经静脉注射上述浓度、体积相同的溶液,观察并记录主动全身过敏性反应情况。阳性对照组分别采用2.0和4.0 mg/ml卵蛋白(OVA)溶液致敏和激发。阴性对照组均采用氯化钠注射液。激发后各组动物眼眶取血并采用酶联免疫吸附法(ELISA)测定血清组胺(HIS)含量。结果阳性对照组动物阳性反应发生率为100%,阴性对照组和灯盏花素注射液0.32和1 mg/kg组动物均未见明显过敏反应。阳性组所有动物血清HIS含量较阴性组均升高,差异有统计学意义(P<0.01),灯盏花素注射液1 mg/kg吸入组动物血清HIS含量较阴性吸入组亦升高,差异有统计学意义(P<0.05)、较阳性吸入组差异无统计学意义(P>0.05)。结论经口鼻吸入灯盏花素注射液1 mg/kg可能存在潜在过敏反应。
OBJECTIVE: To investigate whether systemic hypersensitivity reactions such as piloerection, coughing, dyspnea and even death may be observed after the animals are given breviscapine injection through two different routes of administration, namely sensitization by intraperitoneal sensitization and sensitization by oronasal atomization. Methods The guinea pigs were divided into negative inhalation group, negative injection group, positive inhalation group, positive injection group, breviscapine injection 0.32 and 1 mg / kg inhalation group, injection group. During the sensitization phase, breviscapine inhalation group inhaled the same volume of liquid at different concentrations, administered on alternate days for a total of 3 times. At the same time, the animals in the injection group were injected intraperitoneally with the same concentration and volume of liquid. During the excitation phase, animals in inhalation group inhaled different doses of breviscapine injection on the 14th and 21st days after the last sensitization. The animals in the injection group were intravenously injected with the above solutions of the same concentration and volume to observe and record the active generalized allergic reaction. The positive control group was sensitized and challenged with 2.0 and 4.0 mg / ml ovalbumin (OVA) solutions respectively. Negative control group were used sodium chloride injection. Blood was collected from the orbital eyes of each group after stimulation, and serum histamine (HIS) levels were determined by enzyme-linked immunosorbent assay (ELISA). Results The positive rate of positive reaction in the positive control group was 100%. No obvious allergic reaction was observed in the negative control group and breviscapine injection of 0.32 and 1 mg / kg animals. Compared with the negative group, the serum HIS level of all animals in the positive group was significantly higher than that in the negative group (P <0.01). The serum HIS level in the group in which breviscapine injection 1 mg / kg was inhaled was also higher than that in the negative group Statistical significance (P <0.05), no significant difference compared with positive inhalation group (P> 0.05). Conclusions Oral inhalation of breviscapine injection 1 mg / kg may have a potential allergic reaction.